Bi-lumenal tube catheter support system

ABSTRACT

A catheter having a multilumenal tube surrounded by a slotted hypotube is provided. The catheter has a tube holder that houses the multilumenal tubing and slidably engages the hypotube, and has internal passages configured to receive one of more tubes from the multilumenal tube. The multilumenal tubing separates into one or more tubings, each comprising a lumen, such that the tubings exit the tube holder at different locations. The slotted hypotube slidably engages a key in the tube holder that prevents the multilumenal tubing from rotating relative to the tube holder and the one of more tubings that separate from the multilumenal tubing. Advantages provided by the slotted hypotube/tube holder assembly are described.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 62/168,580, filed May 29, 2015, which isincorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

The present disclosure describes a catheter useful for treating a vesselof a subject. The catheter comprises an outer sheath that surrounds amultilumenal tubing. The catheter further comprises a slotted hypotubethat at least partially surrounds the multilumenal tubing. A tube holderhouses the multilumenal tubing, and the slotted hypotube is configuredto slide within internal passages or channels within the tube holder,such that the hypotube slides relative to both the tube holder and themultilumenal tubing. The slotted hypotube combined with the tube holderprovides advantages over existing catheters further described herein.

BRIEF SUMMARY OF THE INVENTION

Described herein is a catheter comprising an outer sheath surrounding amultilumenal tubing. The catheter can be used for treating vascularlesions. For example, the catheter can be a balloon catheter that isuseful for expanding the diameter of a blood vessel that is narrowed byarteriosclerosis. In one aspect, the proximal end region of the outersheath is connected to a hypotube that surrounds the multilumenaltubing, and the hypotube is configured to slide in a proximal to distaldirection relative to the multilumenal tubing. In some embodiments, thecatheter comprises a multi-lumenal tubing surrounded by a slidablehypotube, and the hypotube has a longitudinal slot. The longitudinalslot is configured to allow a tube that separates from the multilumenaltubing to pass through the slot. In some embodiments, the cathetercomprises a tube holder located near the proximal end that houses themultilumenal tubing. In some embodiments, the tube holder is locatedwhere the multilumenal tubing separates into at least a first and secondtubing. The multilumenal tubing can separate into at least a firsttubing that passes through the longitudinal slot in the hypotube andexits the tube holder at a first location, and at least a second tubingthat exits the tube holder at a second location. In some embodiments,the tube holder comprises internal passages dimensioned to accept thecombined multilumenal tubing that is surrounded by the hypotube and theseparated first and second tubings. The tube holder can comprise a keywithin the passage dimensioned to accept the combined multilumenaltubing, such that the key engages the slot and prevents the hypotubefrom rotating at the position where the multilumenal tubing separatesinto the first and second tubing, while allowing the hypotube to slidewithin the passage dimensioned to accept the combined multi-lumenaltubing. Thus, the slotted hypotube combined with the tube holderdescribed herein provides unexpected advantages, including (i) allowingthe first tubing to separate from the multilumenal tubing at a distallocation, and (ii) preventing rotation of the hypotube, which couldotherwise rotate and cut the first lumen tubing.

In some embodiments, the first location where the first tubing exits thetube holder is located distal to the second location where the secondtubing exits the tube holder. For example, the second location can belocated at a proximal end portion of the tube holder. In someembodiments, the internal passages of the tube holder are connected toeach other at a junction, for example, a Y-shaped junction. The key canbe attached to the tube holder distally of the junction, and thehypotube can surround the second tubing proximal to the junction.

In some embodiments, the hypotube comprises a longitudinal axis and thelongitudinal slot extends at least partially along the longitudinalaxis. For example, the longitudinal slot can extend from a proximal endto a distal end of the hypotube. In some embodiments, the hypotubeslidably extends through the tube holder in a proximal to distaldirection in the internal passage that extends in a proximal directionfrom the junction. In some embodiments, the internal passage thatextends in a proximal direction from the junction comprises the secondtubing.

In some embodiments, the hypotube is C-shaped in cross-section, and thekey engages the open end of the “C.” The key functions to prevent thehypotube from rotating in a circumferential direction. In someembodiments, the catheter further comprises a second key attached to thetube holder that is configured to slidably engage the longitudinal slotof the hypotube. For example, the second key can be attached to the tubeholder at the second location where the second tubing exits the tubeholder. The second key can also engage the longitudinal slot to preventthe hypotube from rotating relative to the multilumenal tubing. Thus, insome embodiments, the longitudinal slot of the hypotube slidably engagesthe first and second keys.

In some embodiments, the hypotube comprises a plurality ofcircumferential slots that extend partially around the circumference ofthe hyptotube. The circumferential slots provide flexibility to helpprevent the hypotube from kinking. The hypotube can be made of metal orplastic.

In some embodiments, the first tubing comprises a guide wire lumen andthe second tubing comprises an inflation lumen. The multilumenal tubingcan be a coaxial tube such that the guide wire lumen tubing issurrounded by the inflation lumen tubing. The guide wire lumen isconfigured to slidably receive a guide wire that extends through theguide wire lumen.

In some embodiments, the tube holder is disposed within a handle locatednear the proximal end of the catheter. In some embodiments, the firsttubing exits the handle at a first location, the second tubing exits thehandle at a second location, and the first location is located distallyrelative to the second location.

Further embodiments will now be described.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a cut-away (sectional) side view of one embodiment of atube holder described herein.

FIG. 1B shows an external side view of one embodiment of a handle for acatheter described herein.

FIGS. 2A and 2B show a representative collar disposed in the “clamshell”of the handle described herein. FIG. 2A shows an isometric view. FIG. 2Bshows an end view.

FIG. 3 shows a cross-sectional view of the collar shown in FIG. 2B incontact with a slotted hypotube described herein.

FIG. 4 shows an isometric view of a representative slotted hypotubedescribed herein.

DEFINITIONS

Unless defined otherwise, technical and scientific terms used hereinhave the same meaning as commonly understood by a person of ordinaryskill in the art. The term “a” or “an” is intended to mean “one ormore.” The term “comprise” and variations thereof such as “comprises”and “comprising,” when preceding the recitation of a step or an element,are intended to mean that the addition of further steps or elements isoptional and not excluded. Any methods, devices and materials similar orequivalent to those described herein can be used in the practice of thisinvention. The following definitions are provided to facilitateunderstanding of certain terms used frequently herein and are not meantto limit the scope of the present disclosure.

The term “about,” when modifying any amount, refers to the variation inthat amount typically encountered by one of skill in the art, i.e., inthe field of angioplasty catheter design. For example, the term “about”refers to the normal variation encountered in measurements for a givenanalytical technique, both within and between batches or samples. Thus,the term about can include variation of 1-10% of the measured amount orvalue, such as +/−1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10% variation.The amounts disclosed herein include equivalents to those amounts,including amounts modified or not modified by the term “about.”

The term “multilumenal tubing” refers to a tube having two or morelumens, such as two, three, four or more lumens. In some embodiments,the multilumenal tubing is a coaxial tube comprising a first innertubing surrounded by a second outer tubing, where each tubing has alumen such that the first tubing is disposed within the lumen of thesecond tubing.

The term “hypotube” refers to an elongate tubular member having aninside diameter that is capable of slidably receiving another tube orshaft. The hypotube is typically cylindrical in shape having alongitudinal axis, a radial axis, and a lumen. Hypotubes can bemanufactured from metals such as stainless steel or nitinol. In someembodiments, the hypotube is made of plastic.

The term “slotted hypotube” refers to a hypotube having a longitudinalslot that extends at least partly along the length or longitudinal axisof the hypotube. The slot comprises an elongate opening that iscontinuous with the lumen of the hypotube and extends partially aroundthe circumference of the hypotube. In some embodiments, the slot isdimensioned such that a tube can exit the hypotube through the slot.

The terms “proximal” and “distal,” when used to describe a catheter,refer to directions towards and away from the cardiologist controllingthe catheter, respectively. For example, the tube holder or handle ofthe catheter described herein is located near the proximal end, and anangioplasty balloon or cardiovascular stent carried by the catheter istypically located at or near the distal end of the catheter. Whenreferring to vascular vessels within the body of a subject, the term“distal” means towards the heart, and “proximal” means away from theheart.

The term “multilumenal tubing” refers to a tube having multiple lumens.Each lumen can be separated from other lumens by a partition or wallthat extends along the longitudinal axis of the tubing. In someembodiments, each lumen is surrounded by a flexible tube. In someembodiments, the tubes are concentric tubes, where one tube is locatedinside another tube, such as, for example, a coaxial tube. In someembodiments, the tubes are not concentric or coaxial tubes.

The term “combined multilumenal tubing” refers to a multilumenal tubethat is not separated into individual tubings that surround a lumen. Forexample, the term refers to the multilumenal tubing that is distal tothe point of separation of the tubings in the tube holder.

DETAILED DESCRIPTION OF THE INVENTION

Described herein is a catheter comprising a multilumenal tubing that issurrounded or covered by an outer sheath, and the multilumenal tubing isat least partially surrounded by a slotted hypotube near the proximalend. The catheter further comprises a tube holder configured to housethe multilumenal tubing and the slotted hypotube. The slotted hypotubeis configured to slide relative to both the tube holder and themultilumenal tubing. The tube holder is further configured to allow themultilumenal tubing to separate into one or more tubings comprising alumen, such that the tubings exit the tube holder at differentlocations. For example, a first tubing can separate from the combinedmultilumenal tubing at a distal end portion of the tube holder, whichprovides the advantage that the length of the lumen is shorter than ifthe first tubing separated from the combined multilumenal tubing at aproximal end of the tube holder. To allow for the first tubing to exitat the distal end portion of the tube holder, the outer sheath comprisesa longitudinal slot that runs parallel to the tubing lumen. The slottedhypotube slidably surrounds the combined multilumenal tubing at thepoint where the first tubing separates from the multilumenal tubing withthe slot oriented to allow the first tubing to pass through easily. Theslotted hypotube slidably engages a key in the tube holder that preventsthe multilumenal tubing from rotating relative to the tube holder andfirst tubing. Thus, the slotted hypotube combined with the tube holderdescribed herein provides the advantages of (i) allowing the firsttubing to separate from the multilumenal tubing at a distal location,and (ii) preventing rotation of the hypotube, which could otherwiserotate and sever the first lumen tubing.

The hypotube described herein is configured to be slidable relative tothe multilumenal tubing, such that the hypotube can slide in a proximalto distal direction (and vice versa, i.e., in a distal to proximaldirection) over the external surface of the multilumenal tubing. Thehypotube comprises a longitudinal slot that allows at least one tube ofthe multilumenal tubing to exit the hypotube. For example, at least afirst tubing can exit the hypotube by passing through the longitudinalslot in the hypotube. The first tubing then exits the tube holder at afirst location. The multilumenal tubing can further separate into atleast a second tubing that exits the tube holder at a second location.In some embodiments, the first location is distal to the secondlocation. In some embodiments, the second location is located at or neara proximal end portion of the tube holder.

The multilumenal tubing can comprise at least a guide wire lumen and aninflation lumen. In some embodiments, the first tubing comprises a guidewire lumen and the second tubing comprises an inflation lumen. In someembodiments, the multilumenal tubing is a coaxial tube. In someembodiments, the tubing comprising the guide wire lumen is surrounded bythe tubing comprising the inflation lumen. In some embodiments, thecatheter comprises a guide wire extending through the guide wire lumen.

The tube holder comprises internal passages or channels that aredimensioned or configured to accept the multilumenal tubing surroundedby the hypotube. The tube holder can also comprise internal passagesthat are dimensioned to slidably receive the tubings (e.g., the guidewire tubing and inflation tubing) that are separated from the combinedmultilumenal tubing. The internal passages of the tube holder areconnected to each other at a junction. In one embodiment, the junctionis a Y-shaped junction. In some embodiments, the internal passage of thetube holder proximal to the junction is dimensioned to accept the second(e.g., inflation lumen) tubing, which surrounds a closed lumen. In someembodiments, the hypotube slidably surrounds the second (e.g., inflationlumen) tubing proximal to the junction. In some embodiments, theinternal passage extending in a proximal direction from the junction isconfigured to slidably receive the hypotube such that the hypotube canslidably extend through the tube holder in a proximal to distaldirection (and vice versa, i.e., in a distal to proximal direction).Thus, the internal passage of the tube holder can be dimensioned toaccept the hypotube that slidably surrounds the second tubing and lumen.In some embodiments, the internal passage(s) of the tube holder surrounda closed lumen.

In some embodiments, the tube holder comprises a first key within theinternal passage dimensioned to accept the combined multilumenal tubing.The key is configured to slidably engage the longitudinal slot of thehypotube and thereby prevent the hypotube from rotating in acircumferential direction (i.e., about its longitudinal axis) at theposition where the combined multilumenal tubing separates into at leastthe first and second tubings. In some embodiments, the hypotube is“C”-shaped in cross section, such that key engages the open end of the“C” and prevents the hypotube from rotating in a circumferentialdirection. The key is further configured to allow the hypotube to slidewithin the internal passages of the tube holder, for example, within aninternal passage configured to accept the combined multilumenal tubing.

The first key is attached to the tube holder distally of the junctionwhere the internal passages connect to each other. The tube holder canfurther comprise a second key that is configured to slidably engage thelongitudinal slot of the hypotube and thereby help prevent the hypotubefrom rotating in a circumferential direction. The second key can engagethe longitudinal slot of the hypotube to help prevent the hypotube fromrotating relative to the multilumenal tubing. In some embodiments, thesecond key is attached to the tube holder at the location where thesecond tubing exits the tube holder. In some embodiments, the second keyis attached to the proximal end portion of the tube holder. To provideadditional anti-rotation stability, the longitudinal slot of thehypotube can slidably engage the first and second keys.

In some embodiments, the hypotube comprises a longitudinal axis and thelongitudinal slot extends at least partially along the longitudinalaxis. The longitudinal slot can extend from the proximal end to thedistal end of the hypotube. In some embodiments, the hypotube comprisesa plurality of circumferential slots that extend partially around thecircumference of the hypotube. The circumferential slots add flexibilityand help prevent buckling of the hypotube. In some embodiments, thecircumferential slots are oriented perpendicular or substantiallyperpendicular to the longitudinal axis of the hypotube. In someembodiments, the width of the slots along the longitudinal axis issubstantially the same. In some embodiments, the width of the slotsalong the longitudinal axis is not uniform, such that some slots arewider than other slots in the proximal-to-distal direction. In someembodiments, the hypotube is made of metal or plastic.

In some embodiments, the proximal end region of the outer sheath isbonded to the slotted hypotube. Alternatively, in some embodiments, theproximal end region of the outer sheath comprises a slot to allow theexit of one or more tubings, such as the guide wire lumen tubing. Inthis embodiment, the outer sheath slidably covers the slotted hypotubesuch that the slot in the sheath aligns with the slot in the hypotube.In another embodiment, the proximal end region of outer sheath isslotted and performs the function of the slotted hypotube. In thisembodiment, the outer sheath is constructed of a rigid material thatresists kinking and buckling, and can comprise circumferential slotsthat add flexibility.

The catheter can comprise a system including the tube holder and ahandle located near the proximal end of the catheter. In someembodiments, the handle comprises a sliding mechanism that is attachedto the proximal end portion of the hypotube. In some embodiments, thesliding mechanism is coupled to the outer sheath of the catheter, andcan be used to retract and/or advance the outer sheath relative to aballoon or stent disposed at the distal end portion of the catheter. Thehandle can further comprise a stress relief structure made of a flexiblethermoplastic elastomer located proximal to the tube holder. In someembodiments, the handle comprises one or more ports connected orattached to one or more tubings of the multilumenal tubing. In someembodiments, the handle comprises one or more ports in fluid connectionwith one or more tubings of the multilumenal tubing. It will beunderstood that the term “fluid” can refer to a liquid or air. In someembodiments, a first port is in fluid connection with the first tubingthat exits the tube holder at the first location. In some embodiments, asecond port is in fluid connection with the second tubing that exits thetube holder at the second location. In one embodiment, the second portis in fluid connection with the inflation lumen tubing. In someembodiments, the second port is located at the proximal end portion ofthe handle. In some embodiments, the first port is located distal of thesecond location on the handle. In some embodiments, the first port isconfigured to accept the first tubing comprising a guide-wire lumen. Insome embodiments, the one or more ports comprise Luer fittings.

The catheter described herein is useful for performing angioplastyprocedures or delivering a device, such as a stent, to a vascular vesselof a subject. The catheter can also be used to treat or otherwisemanipulate other internal vessels or tubes in a subject, such as theurethra. In some embodiments, the catheter is a balloon catheter.

Specific non-limiting embodiments will now be described.

Referring now to FIG. 1, a cut-away view of an illustrative tube holderwill be described. As shown in FIG. 1A, the tube holder (10) (alsoreferred to as a “clamshell”) comprises a proximal end (20) and a distalend (30). The tube holder is connected to the multilumenal tubing (40),which enters the tube holder at the distal end (30). In someembodiments, the multilumenal tubing separates into a first tubing (42)comprising the guidewire lumen and a second tubing (44) comprising theinflation lumen at a Y-shaped junction (50). The tube holder comprisesinternal passages (12, 14) configured to accept the guide-wire lumentubing and the inflation lumen tubing. The guidewire lumen tubing exitsthe tube holder at a first location (60), and the inflation lumen tubingexits the tube holder at a second location (62). The guidewire lumentubing can be attached to a Luer fitting (64) that is attached to thetube holder.

The tube holder (10) further comprises at least a first collar (70)located at the distal end of the tube holder, just distal of theY-shaped junction (50). The collar (70) comprises a key (shown in FIG.2) that is slidably engaged with a slotted hypotube (shown in FIG. 4).The tube holder can further comprise a second collar (72) located at theproximal end of internal passage (14). The collar (72) can also comprisea key that is slidably engaged with the slotted hypotube. In someembodiments, the first and second collars are substantially the same.

As shown in FIG. 1B, the tube holder (10) can be disposed within ahandle (100). The handle comprises a proximal end (120) and a distal end(130). The handle can comprise a Luer fitting (122) at the proximal endthat is in fluid communication with the inflation lumen tubing. Thehandle comprises a slider (112) that is connected to the proximal end ofthe hypotube/outer sheath. The handle can also comprise a stress reliefstructure (140), and a safety handle (150) that is removed prior to use.

Referring now to FIG. 2, an illustrative collar assembly will now bedescribed. FIG. 2A shows an isometric view illustrating the collar (70)having in internal passage (80) and a key (90) that extends into theinterior of the passage (80). The key is configured to slidably engagethe slotted hypotube described herein. FIG. 2B shows an end view of thecollar assembly. In some embodiments, the collar is about 0.125 incheslong. In some embodiments, the internal passage is about 0.056 to about0.058 inches in diameter.

Referring now to FIG. 3, an illustrative collar assembly (70) in contactwith a slotted hypotube (200) will now be described. FIG. 3 shows across-sectional view of the hypotube (200) having a longitudinal slot(210) that is in contact with the key (90) of the collar. The hypotube(200) is typically C-shaped, with the open end of the “C” (210) inslidable contact with the key (90). The hypotube comprises a lumen (230)that is configured to slidably receive the multilumenal tubing (40).

Referring now to FIG. 4, one embodiment of the slotted hypotube will nowbe described. The hypotube (300) comprises a longitudinal slot (310)that extends along the longitudinal axis. In some embodiments, thehypotube further comprises a plurality of circumferentially orientedslots (320) that extend partially around the circumference opposite thelongitudinal slot. In the embodiment shown in FIG. 4, a plurality of thecircumferentially oriented slots are the same width (322) along thelongitudinal axis (i.e., in a proximal to distal direction), whereassome of the circumferentially oriented slots are wider (324) along thelongitudinal axis and are interspersed among the other slots (322). Thecircumferentially oriented slots provide flexibility and preventbuckling of the hypotube. In some embodiments, the slotted hypotube isabout 20 cm long.

It is understood that the examples and embodiments described herein arefor illustrative purposes only and that various modifications or changesin light thereof will be suggested to persons skilled in the art and areto be included within the spirit and purview of this application andscope of the appended claims. All publications, patents, and patentapplications cited herein are hereby incorporated by reference in theirentirety for all purposes.

What is claimed is:
 1. A catheter comprising: a multi-lumenal tubingsurrounded by a slidable hypotube, the hypotube having a longitudinalslot; a tube holder where the multi-lumenal tubing separates into atleast a first tubing that passes through the longitudinal slot in thehypotube and exits the tube holder at a first location and at least asecond tubing that exits the tube holder at a second location; and wherethe tube holder comprises internal passages dimensioned to accept thecombined multi-lumenal tubing surrounded by the hypotube and theseparated first and second tubings, and where the tube holder comprisesa key within the passage dimensioned to accept the combinedmulti-lumenal tubing, such that the key engages the slot and preventsthe hypotube from rotating at the position where the multilumenal tubingseparates into the first and second tubing while allowing the hypotubeto slide within the passage dimensioned to accept the combinedmulti-lumenal tubing.
 2. The catheter of claim 1, wherein the firstlocation is distal to the second location.
 3. The catheter of claim 1,where the second location is at a proximal end portion of the tubeholder.
 4. The catheter of claim 1, where the internal passages areconnected to each other at a junction.
 5. The catheter of claim 4, wherethe junction is Y-shaped.
 6. The catheter of claim 4, where the key isattached to the tube holder distally of the junction.
 7. The catheter ofclaim 4, where the hypotube surrounds the second tubing proximal to thejunction.
 8. The catheter of claim 1, where the hypotube comprises alongitudinal axis and the longitudinal slot extends at least partiallyalong the longitudinal axis.
 9. The catheter of claim 1, wherein thelongitudinal slot extends from a proximal end to a distal end of thehypotube.
 10. The catheter of claim 1, where the hypotube slidablyextends through the tube holder in a proximal to distal direction in theinternal passage comprising the second tubing.
 11. The catheter of claim1, wherein the hypotube is C-shaped in cross-section, and the keyengages the open end of the “C.”
 12. The catheter of claim 1, whereinthe key prevents the hypotube from rotating in a circumferentialdirection.
 13. The catheter of claim 1, further comprising a second keyattached to the tube holder and configured to slidably engage thelongitudinal slot of the hypotube.
 14. The catheter of claim 13, wherethe second key is attached to the tube holder at the second location.15. The catheter of claim 14, where the second key engages thelongitudinal slot to prevent the hypotube from rotating relative to themultilumenal tubing.
 16. The catheter of claim 14, where thelongitudinal slot of the hypotube slidably engages the first and secondkeys.
 17. The catheter of claim 1, wherein the hypotube comprises aplurality of circumferential slots that extend partially around thecircumference of the hyptotube.
 18. The catheter of claim 1, where thefirst tubing comprises a guide wire lumen and the second tubingcomprises an inflation lumen.
 19. The catheter of claim 18, where themultilumenal tubing is a coaxial tube and the guide wire lumen tubing issurrounded by the inflation lumen tubing.
 20. The catheter of claim 18,further comprising a guide wire extending through the guide wire lumen.21. The catheter of claim 1, where the hypotube is made of metal orplastic.
 22. The catheter of claim 1, where the tube holder is disposedwithin a handle.
 23. The catheter of claim 22, where the first tubingexits the handle at a first location, the second tubing exits the handleat a second location, and the first location is distal to the secondlocation.
 24. The catheter of claim 1, where the catheter is a ballooncatheter.